ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure

Phase 3 Study of Alprostadil Continuous Intravenous Infusion to Maintain Clinical Stability in Severe Heart Failure Patients

This is a global multicenter, doubleblind, placebo-controlled, randomized, parallel-group study that compares ALP-1 given in a continuous infusion ( compared to placebo), 250mcg/day on majore outcomes up to 6 months after randomization in participants with advanced HF with reduced ejection fraction(HFrEF).

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Cardiac Failure; HFrEF - Heart Failure With Reduced Ejection Fraction; NYHF Class III-IV
• Intervention / Treatment: Drug: Alprostadil

Detailed Description

We anticipate needing to screen ca. 600 patients in order to ransomize our target sample size of 400 participants. Participants will be randomozed 1:1to receive either alprostadil or placebo. Based on prior data, we expect the 6-month event rate to be 64% in the control group and 47% in the intervention group.

The planned duration of following-up for each patient is 6 months on the randomized trial intervention and a final follow-up visit will be performed 30 days after stopping the trial intervention. Eligible patients will be randomzied via a centralized IXRS to eith alprstadil or placebo. The planned study dusration is approximately 3-4 years from first randomized patient to last patient.

When a participant is deemed eligible to participate in the trial, a central line which will be used for infusion of double-blind treatment will be inserted, if not already in place. Continue infusion delivery system will be operated by a pump.

Infusion of trial intervention will be initiated while the participant is in the hospital of infusion centre and the participant is to remain under observation for at least 8 hours for monitoring of vital signs and adverse event(AEs).

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pei K Wang, MD; Phone Number: +886227720395; Email: pei@biopeutics.com
• Study Contact Backup: Name: Emily Tai, MA; Phone Number: +886227720395; Email: emilytai@biopeutics.com

Study Locations

• Austria
  • Vienna, Austria
    • Medical University Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

1. Patients older than 18 years of age, of any gender/sex and race/ethnicity

2. Patients with a diagnosis of advanced HFrEF as evidenced by (all must apply):

   1. most recent LVEF( by conventional imaging method<30% which was mwasured within 3 months prior randomization.
   2. Nt-proBNP >1500 ng/L or BNP >300 ng/L at prior randomization
   3. New York Heart Association (NYHA) functional class IIIb or IV, i.e., chronic dyspnoea or fatigue at rest or with minimal exertion for at least one month prior to consent.
   4. Renal dysfunction reflected by a glomerular filtration rate (GFR) <60 mL/min approximated by the Modification of Diet in Renal Disease formula.
   5. A total symptom score of KCCQ of <70measure within 24 hours of randomization
   6. Patients on all appropriate recommended HF therapy.
3. Patient should not be receiving continuous or planned intermittent intravenous infusions with a positive inotropic or vasodilator drug in a non-hospitalized setting
4. Patients should not be considered as candidates for heart transplantation or LVAD for at least 6 months from randomization according to the opinion of the treating physician.

5. Women of childbearing potential (i.e., who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must commit either to abstain continuously from heterosexual sexual contact or to use at least one "highly effective" method of birth control (e.g., intrauterine device [IUD], hormonal contraception, tubal ligation, or partner's vasectomy) or two "effective" methods (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to screening and throughout study participation.

   Note: As alprostadil is not genotoxic and female sexual partners of male study participants are not likely to have substantial exposure via semen, there are no contraception requirements for men.

6. Patients must be willing and able to give written informed consent, including local data privacy consents, as required

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: trial arm; 6 months central continuous infusion with Alp_1 by infusion pump.	Drug: Alprostadil; central venous access continuous delivery with 500mcg/48 hours in active arm
Placebo Comparator: Placebo arm; 6 months central infusion with NS by infusion pump with exact infusion rat as trial arm.	Drug: Alprostadil; central venous access continuous delivery with 500mcg/48 hours in active arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to all-cause mortality (defined as death, heart transplant, LVAD placement, mechanical circulatory support, or HF event(* hospitalization for HF or unplanned intravenous therapy for HF, ie diurectics, inotropes, vassopressors, or vasodilators.)	To access the effect of continue 6-months ALP-1infusion at a fixed dose of at 500mcg/48 hr. in patinets with advanced heart failure with reduced ejection fraction(HrEF) compare to placebo.	6 months infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy and Safety Endpoints	. physcians review NYHA HF functional classification	6 months

Collaborators and Investigators

• Sponsor: Biopeutics Co., Ltd
• Investigators: Principal Investigator: Martin Huelsmann, MD, Medical University Vienna, department of Cardiology; Principal Investigator: Noemi Pavo, MD PhD, Medical University Vienna, department of Cardiology

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: January 14, 2008
• First Submitted That Met QC Criteria: February 6, 2008
• First Posted (Estimated): February 7, 2008

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: advanced HFrEF
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Fatty Acids; Lipids; Biological Factors; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Fatty Acids, Monounsaturated; Prostaglandins E; Alprostadil
• Other Study ID Numbers: 3-T02-07-0106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No